ROSA Knee System with UltraSound Imaging Platform (USIP)— 510(k) K252058
Substantially EquivalentBalmoral Medical, LLC
FDA 510(k) clearance K252058 for ROSA Knee System with UltraSound Imaging Platform (USIP), Substantially Equivalent on 2026-02-06. Applicant: Balmoral Medical, LLC. Device class: 2.
Summary
Balmoral Medical's ROSA Knee System with UltraSound Imaging Platform (USIP) is filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Balmoral Medical filed from Rosemont, Illinois. The substantially equivalent decision came 220 calendar days after receipt (July 1, 2025 to February 6, 2026).
Clearance details
- Applicant
- Balmoral Medical, LLC
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosemont, IL, US
Recent devices under product code OLO
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.